Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

Gastric Cancer Clinical Trial

Official title:

Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471756
• Other study ID #: 10-008104
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2011
• Last updated: September 5, 2014
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

Description:

The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sessile colorectal polyp

• laterally spreading lesions as defined by Paris Classification type II and > 1 cm or greater

Exclusion Criteria:

• Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma

• Inflammatory bowel disease patients

• Coagulopathy ( INR> 1.5) that cannot be corrected

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• Standard of Care Procedure as described in ARM
Standard of Care Procedure as described in ARM

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	US Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Two Devices used in EMR	To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" .	1 year	No
Secondary	Compare the Use of Two Injectates	To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.	1 year	No